Newport Beach, California, USA – Pharmaceutical and medical device manufacturers can dedicate many years, and millions of dollars, to bring a new drug or product to the marketplace. One of the common problems facing companies conducting international or global clinical trials is knowledge of the regulatory requirements in each country. Now, a new consulting service offered by translation and interpreting firm Global Language Solutions® (GLS) can result in an investigational drug entering clinical trials sooner by shortening the labeling and translation processes. The new service, which will be provided by industry expert Dr. David Bernstein, is estimated to shorten the regulatory compliance, translation, and back translation process from 2-3 weeks to less than one week. More importantly it will minimize or eliminate any delays to the labeling process should the local or regional Ministry of Health request additional label text that is required in its region.
Often smaller or virtual companies may not have access to or knowledge of the translation and labeling requirements – which can vary from country to country and are based on the specific requirements of each Ministry of Health (especially in the EU and Australia) or the U.S. Food and Drug Administration. Adds Bernstein, “The text for labels and booklet labels varies from region to region, as well as the language these materials must be translated into. Often clinical packaging contract organizations cannot provide expertise in this area or offer any guidance. This alliance will help avoid disconnects between companies and their CROs, as well as rapidly increase the turnaround time for obtaining investigational labels.”
Inna Kassatkina, president of GLS, comments, “As medical device manufacturers and pharmaceutical companies continue to expand into other regions of the globe, either via product exportation or global clinical trials, we have seen a significant desire from our clients for regulatory compliance services. By offering regulatory, not only is the labeling process significantly expedited, but GLS’ clients are also benefiting from an industry leader.”
At this time, the firm is providing regulatory compliance consulting for the U.S., Canada, Mexico, European Union, Australia and New Zealand, Russia, and others upon request.
Visit www.globallanguages.com or call +1-949-798-1400 for more information about GLS and its pharmaceutical and clinical research translation and regulatory compliance services.
About Global Language Solutions®
Global Language Solutions® (GLS) is a full-service ISO 9001:2000 certified translation company delivering solutions in over 100 languages to increase its clients' multicultural and international market share. GLS provides culturally and linguistically accurate document translations, linguistic validation, website localization, multilingual graphic design, conference interpreting, voice-overs, and more. The company's clients are leading healthcare, pharmaceutical, medical devices, biomedical, and clinical research organizations. GLS is a WBENC-certified Women’s Business Enterprise (WBE) based in Newport Beach, California. For more information, visit www.globallanguages.com or call +1-949-798-1400.
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